MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problems
Insufficient Flow or Under Infusion (2182); Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)
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Patient Problems
Cerebrospinal Fluid Leakage (1772); Headache (1880); Muscular Rigidity (1968); Pain (1994); Seroma (2069); Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/21/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id 8780, serial# (b)(4), implanted: (b)(6) 2020, product type catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 28-feb-2022, (b)(4).If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from a consumer on 2021-jan-05 regarding a patient receiving fentanyl (1500mcg/ml at 99.92mcg/day) via an implanted infusion pump.It was reported that the patient went home on (b)(6) 2020 after their pump was implanted and had a confirmed spinal headache for 10 day straight.During this time the patient had to be flat in bed.The patient reportedly got over that, but still had migraines although they were not the spinal headaches where the patient couldn't even stand.The patient also had back aches and no pain relief.The doctors reportedly told the patient that if they had a cerebrospinal fluid (csf) leak, they would experience back aches and migraines, and the patient did have those symptoms.The patient told their healthcare provider (hcp) but they were not concerned that the patient had a csf leak.The patient thought that they had a csf leakbecause every time they got a bolus they got a "goose egg" of liquid on their back.The patient stopped giving themselves boluses on (b)(6) 2020 and had not had a goose egg since.The patient also heard ticking when they got a bolus.It was confirmed that the hcp told the patient that the bolus was very small amount, but the patient wanted to rule out a csf leak.The patient had a refill on (b)(6) 2021 and they changed the concentration from 500mcg/ml to 1500mcg/ml since the patient had not had any pain relief for 5 weeks.The patient underwent magnetic resonance imaging (mri) of the neck due to the pain that the patient believed was caused by the headaches.Additional information was received from a consumer on 2021-feb-24.It was reported that the patient was still not getting pain relief, despite increases to her dose.She did get some relief of spasticity from the boluses.She had a dye study performed on (b)(6)2021 to rule out catheter issues and no anomalies were found.She was "locked out" of her ptm for three days following the dye study.She also mentioned that at her refill on (b)(6) 2021 they expected to withdraw 2.5ml but actually withdrew 10ml.No further complications were reported.
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Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received from a consumer indicated the patient had 'zero basal relief' from pump medication, but the patient got relief from blousing, which the patient was allowed 8x/day.This resolved neuropathic pain, but not back pain as intended.It was noted the patient was "screaming about 1 hour until the next one".The patient inquired if there was a maximum amount of boluses the healthcare provider (hcp) could set.It was noted the patient was to have another dye study and asked if that study came back normal, what should the doctor check for.The patient had been going to the hcp twice a week for titrations with no relief.The patient was to follow-up with the physician.
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Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information reported that the patient was going to get an interventional radiology study to look at the catheter to rule out an occlusion.The patient was wondering if they do a priming bolus, will that take away one of her bolus's as she will only have 5 bolus's left.It was reviewed the priming bolus would not use any of her bolus's.After the priming bolus the patient may belocked out of the ptm for estimated 15-20 min.Additional information was received from the patient on (b)(6) 2021 who reported that they did the study to rule out any occlusion or leak and both were negative.The study showed that the catheter is at t10 but her operative report says it was sutured in at t8.The patient asked why that would be different.The patient mentioned that she "never had spasticity until 6 weeks post op and it's profound when i lay down." and also stated that "at bedtime i need these boluses like crazy, the pain is off the charts." the patient stated that the fentanyl used in her trial helped with the pain but since they put drug in her pump on dec.3 she has been without any relief.The patient asked about flex dosing and the agent reviewed programming options for flex versus use of ptm.
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Manufacturer Narrative
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Concomitant medical products: product id 8780, lot#/serial# (b)(6), implanted: (b)(6) 2020, product type catheter.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received from the consumer indicated that the patient's medication got switched to bupivacaine(marcaine) and dilaudid.It was noted that the medication was working for them.
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Event Description
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Additional information was received from the consumer, indicated that they continued to get no pain relief.It was reported, that the patient was going to see the managing physician today.And wanted to discuss how the pump bulges and presses against the navel.And is uncomfortable, since implant.The patient wanted a physician listing, so she can have the pump removed.
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Manufacturer Narrative
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Concomitant medical products: product id: 8780, serial# (b)(6), implanted: (b)(6) 2020, product type: catheter.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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